Clinical Research Offices Newsletter
UWCCC Disease Oriented Working Groups (DOWGs) & Leaders
CRO Open
House
The CRO will be hosting an Open House
on Thursday August
18, 2011 from 3:30
to 5:00 PM in the
CSC K4/6 central
common area.
Please join us for
light appetizers and
beverages and the
opportunity to meet
and mingle with others from around the
UWCCC, the SMPH,
and the UW campus.
We look forward to
seeing you there!
Each month we will highlight a DOWG or other UWCCC Research Group.
•
What is a DOWG? A DOWG is composed of clinical, translational and basic researchers and
research staff focused on performing multi‐translational cancer related clinical research fo‐
cused on prevention, diagnosis and treatment of disease specific areas of cancer
•
Each DOWG provides administrative, regulatory, fiscal and clinical oversight for the facilita‐
tion and conduct of clinical research within their disease‐specific research group.
• The DOWG typically includes the following members:
 Designated Leader with a faculty position and is a UWCCC member. Other members of
the DOWG include:
 Clinical and laboratory faculty and staff
 Program manager
 Study coordinators and regulatory specialists
UWCCC DOWG of the Month: Breast DOWG
Who is in the Breast DOWG? Torie Dzelak is the Program Manager. Tam‐
my Koehn is a study coordinator. Breast had a new study coordinator start
in June, Sarah Donohue. The co‐leaders for the Breast DOWG are Mark
Burkhard, M.D., PhD and Lee WiIke, M.D. Drs. Kari Wisinski and Amy
Tevaarwerk are also breast oncology physicians that serve as Principal Investigators on
many of the breast protocols. Torie has been the PM for over 3 years and recently be‐
came Torie Champeny as she exchanged wedding vows in the Dominican Republic on
June 28! Tammy is currently pregnant with twins and on bed rest until their arrival in
September. Sarah joined the breast group as a former student with the OnCore Sup‐
port Team. The breast DOWG currently has approximately seven protocols open, with
nine new protocols getting ready for activation. They also have 203 patients in long‐
term follow‐up.
July 2011 - Issue #2
Page 2
Clinical Research Services Office Updates
CRSO Contact Info
Sarah Marco e
CRSO Program Manager
[email protected] 263‐7898 Laila Borokhim
VA Research Coordinator
[email protected] 262‐0694 Vielska Brau gam
Budget Compliance Specialist
vmbrau @uwcarbone.wisc.edu 262‐8980 Belinda Buehl‐Soppe
Protocol Development Specialist
[email protected] 262‐8582 Lynn Volk
Outreach/Affiliate Coordinator
[email protected] 265‐8670 Mary Beth Wims
Outreach/Affiliate Coordinator
[email protected] 263‐1258 The Affiliate Office is responsible for com‐
municating with all sites affiliated with the
UWCCC. One important group of affiliates
is the regional partners (RPs).
Regional partners are sites who have en‐
tered into a special contract with the
UWCCC. They agree to follow UWCCC poli‐
cies for research processes and regulations,
and in turn, the UWCCC offers protocol‐
level support to the sites in developing and
conducting research studies at those sites.
Nearly all external sites who have UW per‐
sonnel on staff are RP sites. Each RP site
has a UW radiation oncologist on staff. One
RP also has a medical oncologist who is a
UW faculty member.
The current regional partners are:
 Beloit Memorial Hospital, Beloit, WI
 L.C. Ferguson Cancer Center, Freeport,
IL
The CRO is holding a
logo design contest for
WON! Please submit
your logo designs to
affiliatecoordina‐
[email protected]
du by August 5, 2011.
The winner will be re‐
vealed at the upcoming
CRO Open House Au‐
gust 18, 2011. Good
luck!!!!!
OnCore Financials V is currently being trained by the Institute for
Clinical and Translational Research (ICTR) folks
on the details of OnCore Financials. V will be
aiding in the development of tutorials and Da‐
ta Field Definitions (DFDs) for DOWGs/RGs. In
addition, Sarah and V are working on develop‐
ing a training agenda/curriculum for UWCCC
Staff and are currently finalizing workflow is‐
sues and discussing plans for implementation
of OnCore Financials in the Fall. So stay tuned!
Budget Sub‐Committee
The UWCCC Program Manager’s Budget Sub‐
Committee members are currently working on
revisions to the format of the UWCCC Stand‐
ard Budget Guidelines for clinical research pro‐
tocols. IRB fees will be updated to clearly indi‐
cate to sponsors that we have an institutional
IRB fee as well as a DOWG/RG IRB preparation
and submission fee.
 UWCCC—Johnson Creek, Johnson
Creek, WI
 UWCCC—Riverview, Wisconsin Rapids,
WI
Wisconsin Oncology
Network (WON)
LOGO Contest!
BUDGET NEWS
Regional Partners of the UWCCC
 Note: UW Health Oncology at 1 South
Park is a satellite clinic of the UWCCC,
NOT a regional partner
ECOG Grant Allocations
All Program Managers were sent their groups’
ECOG Grant allocation for salaries for July 2011
through April 30, 2012. Please let V know by
the end of August the details of salary alloca‐
tions.
Introducing New CRSO Staff
Laila Borokhim is the new VA Re‐
search Coordinator for the
UWCCC. In this new position,
Laila hopes to help streamline the
process and make it easier for can‐
cer research trials to open at the
VA. Veterans and their families are an especially im‐
portant part of this nation’s population who deserve to
have access to cancer research trials. Currently, Laila
is working on the IRB application for a lung cancer pro‐
tocol. Please feel free to contact Laila at lbor‐
[email protected].
WON Membership Update
Aurora Advanced Healthcare and
the Aurora Healthcare Network
recently joined WON. The 17 sites
that comprise these two institutions
nearly double the size of WON.
Both Dr. Traynor and the Affiliate
Office are extremely excited to wel‐
come the Aurora system and look
forward to the increased accrual
potential of the network.
July 2011 - Issue #2
Page 3
Clinical Research Compliance Office Updates
CRCO Contact Info
Shari Zeldin
CRCO Program Manager
[email protected] 263‐8403 Rachel Crawford
PRMC Coordinator
[email protected] 263‐0169 Emily Jenner
Compliance & Monitoring Coordina‐
tor
[email protected] 262‐9654 DSMC Corner


Until we have an elec‐
tronic monitoring sys‐
tem available, please
remember to print out
all pertinent notes and
results from HealthLink
such as H&Ps, lab re‐
sults, etc. and place
them in the research
chart. These should be
available for all internal
monitoring or auditing
visits as one of the prin‐
ciple goals of these visits
is to ensure protocol
adherence.
For all submissions to
DSMC( protocol devia‐
tion reports, protocol
summary reports, etc),
please remember to
reference the cancer
center number in the
email subject line. This
is especially important
for individual monitoring
reports from industry
sponsors as the sponsor
number is often the only
number listed on these.
PRMC Corner: Help us Help You! We in the Compliance Office are continually striving to develop new processes to help reduce the
timeline from PRMC review to approval so the protocol can move on to the IRB. In review, we found
that one of the most common reasons for receiving an “Approval Pending” decision at the PRMC
(which results in delays) rather than a straight out “Approval” is that the protocol lacks important
information regarding Data and Safety Monitoring (DSM). It is a required element of a protocol to
elaborate on the processes that are in place to monitor the safety data at specific intervals, to de‐
scribe what those processes are, and to ensure that a body of individuals (whether it be a board or a
committee) oversee the safety of the subjects on the trial.
In an attempt to alleviate these delays in ‘Approvals”, we have revised the ePRMS Submission Short Form to now include a section pertaining specifically to DSM and where that information can be
found in the protocol. (For those of you who have been here awhile, you may remember that this
used to be in the form. We have simply put it back in the form so that the research groups will en‐
sure they include the DSM information and then protocols won’t get held up at the PRMC because
this information is missing and we have to come back to the groups to get the info!)
The committee does not approve protocols without a Data and Safety Monitoring Plan commensu‐
rate with the level of risk or sufficient information regarding DSM processes. The ePRMS Submis‐
sion Short Form now includes the following section:
Some additional PRMC Tidbits: Please make certain not to submit to ARROW until you submit to PRMC AND receive PRMC
Approval. PRMC will now be sending the ARROW submissions back to you as an
“Approval Pending” if you mistakenly send it to ARROW before PRMC Approval is re‐
ceived.
When completing submissions in ARROW, it is imperative to include the Cancer Center proto‐
col number or the Cooperative Group number in the Short Title of the ARROW submission
in order for us to be able to easily identify the study—which saves time in getting out your
approvals!
Education & Training Corner: Refresh Yourself!
Believe or not, it has been almost 3 years since we completed our initial Human Subjects Training
in CITI. As you may remember, a refresher course is required every 3 years. Many UWCCC staff
have already had to complete their human subjects training refresher course. Others will do the
same in the coming months. Some UWCCC staff and faculty members have not received the re‐
fresher course reminder email from the UW Office of Research Policy instructing them to complete
their training. The refresher course will not show up on your “Course Page” in CITI until approxi‐
mately 3 months prior to your human subjects training expiration. We advise all to go back and
confirm what month in 2008 the initial training was completed so you will know when the refresh‐
er course will be available. Remember, the IRB will not review protocols if the key personnel listed
have expired human subjects training!
July 2011 - Issue #2
Page 4
OnCore Support Team Updates
OnCore Support
Contact Info
Various “widgets” are available in OnCore that can be personalized to provide shortcuts to
your most used sections. Widgets can be set up to appear on your home screen by clicking
the gear button (see a. below) in the upper right hand corner of the screen. All widgets con‐
tain hyperlinks when displayed that will allow you to efficiently navigate to the items you
use most in OnCore.
Stephine Wasielewski
Manager, OnCore Support Office
[email protected] 263‐2907 Divya Kudva
OnCore Support Staff
[email protected] 262‐6604 Arenda Nolan
OnCore Support Staff
[email protected] 262‐6604 Introducing New OnCore Staff
Arenda
Nolan just
started at
the Can‐
cer Cen‐
ter On‐
Core Sup‐
port
Office in
June 2011. Arenda recently
moved from Ohio where she
worked at the OSU Medical
Center doing cancer research for
4 years. Arenda is really enjoy‐
ing Madison, especially the out‐
door activities and the great
food! She is in the process of
learning OnCore, and is looking
forward to helping others with
it.
Protocols Widget
This widget displays all of your bookmarked protocols. You can bookmark a protocol in the
PC Console by clicking the star in the upper left corner to turn it yellow. [
] To un‐
bookmark, simply click it again and it will change to white. The Widget is customizable by
clicking on the gear button (see b. above) within the widget once you have selected to dis‐
play it on your homepage. This will allow you to choose what information is displayed on the
home page. You can click on the expand button (see c. above) to view further information.
Subjects Widget
This Widget displays all bookmarked subjects. The display can be customized and expanded
similar to Protocols Widget (see above).
SAEs Widget
This widget displays all SAEs on your bookmarked subjects and/or protocols. Display can be
customized similar to Protocols Widget (see above).
Reports Widget
This widget displays a list of all recently run reports. It is not customizable or expandable.
Note: OnCore version 11.0 (coming soon) includes a new widget Saved Protocol Searches that can
display protocol searches that you have saved.
July 2011 - Issue #2